EUCTR2020-000553-27-BG进行中（未招募）1 期
A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,605
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Otherwise healthy participants are eligible to be included in the study only if all of the following criteria apply:
- •1.The participant is =12 years of age at the time of signing the informed consent/assent and has a body weight =40 kg.
- •Note: Although participants as young as 12 years may enroll in the study, study sites must follow their institutional ethics committee and local country/national regulatory guidelines and enrollment will be contingent upon such approvals regarding the allowed lower age limit for clinical study participants.
- •Type of Participant and Disease Characteristics
- •2.The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset =96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain (see Appendix 5).
- •3.The participant has nitrite or pyuria (>15 WBC/HPF or the presence of 3+/large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.
- •4. The participant is female.
- •Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •A female participant is eligible to participate if she is a woman of childbearing potential (WOCBP) who is not pregnant as confirmed by a high sensitivity urine pregnancy test at Baseline (Day 1) regardless of current or prior contraception use or abstinence, is not breastfeeding, or is not a WOCBP.
- •Note: Pregnancy testing requirements, contraceptive guidance, and WOCBP definitions are provided in Appendix 2 and Appendix 6.
- •Additional requirements for pregnancy testing during and after study intervention are located in Appendix 6.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Informed Consent
- •5.The participant is capable of giving signed informed consent/assent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)/assent form and in this protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 960
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •-The participant resides in a nursing home or dependent care typefacility
- •AND has a body mass index =40.0 kg/m2 or a body mass index =
- •35.0kg/m2 and is experiencing obesity-related health conditions such as
- •uncontrolled high blood pressure or uncontrolled diabetes.
- •- Participant has a history of sensitivity to the study treatments, or
- •components thereof, or a history of a drug or other allergy.. that,
- •contraindicates her participation.
- •- Participant is immunocompromised or has altered immune defenses
- •that may predispose the participant to a higher risk of treatment failure
- •and/or complications, and participants receiving immunosuppressive
- •therapy, including corticosteroid therapy.
- •-Participants with a known CD4 count of <200 cells/mm3 should not be
- •-Participant has any of the following: /Medical condition that requires
- •medication that may be impacted by inhibition of acetylcholinesterase,
- •such as: Poorly controlled asthma or chronic obstructive pulmonary
- •disease at Baseline and, in the opinion of the investigator, not stable on
- •current therapy/Acute severe pain, uncontrolled with conventional
- •medical management/Active peptic ulcer disease/Parkinson
- •disease/Myasthenia gravis/A history of seizure disorder requiring
- •medications for control/known Acute porphyria/any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion of the study treatment.
- •-Participant has a known glucose-6-phosphate dehydrogenase deficiency
- •and in the judgment of the investigator, would not be able or willing to
- •comply with the protocol or complete study follow-up.
- •-Participant has a serious underlying disease that could be imminently
- •life-threatening, or the participant is unlikely to survive for the duration
- •of the study period.
- •-Participant has acute cystitis that is known or suspected to be due to
- •fungal, parasitic, or viral pathogens
- •-Participant has symptoms known or suspected to be caused by another
- •disease process,ex overactive bladder, chronic incontinence, or chronic
- •interstitial cystitis, that interfere with the clinical efficacy assessments or preclude complete resolution of acute cystitis symptoms.
- •-Participant has an anatomical or physiological anomaly that predisposes
- •the participant to UTIs or may be a source of persistent bacterial
- •colonization, including calculi, obstruction or stricture of the urinary
- •tract, primary renal disease, or neurogenic bladder, or the participant
- •has a history of anatomical or functional abnormalities of the urinary
- •-Participant has an indwelling catheter, nephrostomy, ureter stent, or
- •other foreign material in the urinary tract.
- •-Participant who, in the opinion of the investigator, has an otherwise
- •complicated UTI, an active upper UTI, signs and symptom onset =
- •96hours before study entry, or a temperature =101°F- (=38°C), flank pain, chills,
- •or any other manifestations suggestive of upper UTI.
- •-Participant has known anuria, oliguria, or significant impairment of
- •renal function or presents with vaginal discharge at Baseline.
- •-Participant has congenital long QT syndrome or known prolongation of
- •the corrected QT (QTc) interval.
- •-Participant has uncompensated heart failure.
- •-Participant has severe left ventricular hypertrophy.
- •-Participant has a family history of QT prolongation or sudden death OR
- •has a recent history of vasovagal syncopeor episodes of symptomatic
- 另有 2 项未显示
研究者
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